Quality Assurance Specialist (m/w/d) 100%

• Type of Employment: temporary through nemensis ag, 100%
• ID: 22707
• Duration: 01.04.2025 - 31.12.2025
• Salary: CHF 9000 monthly - CHF 10900 monthly
• Location: Schachen, Luzern

Responsibilities

• Collaborate with external partners to achieve business goals and foster a shared culture that benefits the company, external partners, and patients
• Take technical responsibility for the commercial manufacturing process, including change control, process improvement projects, statistical process analysis, and investigation of deviations
• Support technology transfers by authoring and/or reviewing GMP documentation (Master Batch Records, change control, protocols, reports, qualifications, regulatory filings)
• Provide on-site coverage at external partners for commercial production and technology transfer activities
• Implement and standardize GMP requirements in collaboration with operations, quality, and external partners
• Ensure external partners are inspection-ready for routine inspections and product-related inspections
• Participate in the creation, implementation, and sharing of best practices and business process strategies

Requirements

• Bachelor's degree in Chemical/Biochemical Engineering, Pharmaceutical Science, Chemistry/Biology, or a related field
• Minimum of 4 years of post-bachelor's experience in a GMP functional area or supporting a GMP functional area (e.g., Operations, Technical Operations, Technology, Engineering, or Maintenance)
• Willingness to travel approximately 25%
• Strong communication and teamwork skills in English
• Experience in biologics drug substance upstream and downstream operations, analytical testing, process development, and tech transfer preferred
• Ability to manage projects independently and meet deadlines
• Experience in statistics, including Proactive Process Analysis and Continuous Process Verification
• Experience in deviation management, change control, equipment support, or project management

Benefits at nemensis ag

• Nemensis ag is your specialized recruitment partner in the Life Sciences sector based in Basel
• Comprehensive guidance and support throughout the application process by our consultants
• Access to a large network of clients and exciting positions in Northwestern Switzerland
• Quick and seamless onboarding with individualized support and guidance during the application process

About Us

At nemensis ag, we have helped thousands of candidates find their dream jobs and offer opportunities for career development or re-entry into the job market.

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Contact: Kristina Mutidi, Consultant, Write an email

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